# Purebeau New Cosmetics Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Purebeau New Cosmetics Gmbh · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles; product code is 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 04 Tattoo Ink | 79 O - - AB System ablations, low energy direct current and accessories; date published is 11/01/2017; address is Mozartstr. 12 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.

- **Firm:** Purebeau New Cosmetics Gmbh _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** GERMANY _(verified: appears in the quote below)_
- **Address:** Mozartstr. 12 , Berlin, Berlin GERMANY _(verified: appears in the quote below)_
- **Date published:** 11/01/2017 _(verified: appears in the quote below)_
- **Product code:** 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 04 Tattoo Ink | 79 O - - AB System ablations, low energy direct current and accessories _(verified: each item appears in the quote below)_
- **Product:** Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Purebeau New Cosmetics Gmbh Date Published : 11/01/2017 Mozartstr. 12 , Berlin, Berlin GERMANY 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 53 Y - - 04 Tattoo Ink Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 79 O - - AB System ablations, low energy direct current and accessories Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).